Lipitor（Atorvastatin Calcium）是由辉瑞公司研发的降脂药。为治疗高胆固醇血症、冠心病或冠心病等危症（如：糖尿病，症状性动脉粥样硬化性疾病等）合并高胆固醇血症或混合型血脂异常的患者，本品适用于：降低非致死性心肌梗死的风险、降低致死性和非致死性卒中的风险、降低血管重建术的风险、 降低因充血性心力衰竭而住院的风险、降低心绞痛的风险。
起始剂量为；10mg，每日一次。剂量调整时间间隔应为4周或更长。本品最大剂量为80mg，每日一次。阿托伐他汀每日用量可在一天内的任何时间一次服用
批准日期：2005年 研发公司：辉瑞
LIPITOR(阿托伐他汀钙[atorvastatin calcium]) 片，供口服使用
首次美国批准：1996
近期重大变化
剂量和给药量：10/2012
警告和注意事项：10/2012
药物相互作用：02／2012
作用机理
LIPITOR是HMG-CoA还原酶的选择性竞争性抑制剂，它是将3-羟基-3-甲基戊二酰辅酶A转化成甲戊酸的限速酶，是包括胆固醇在内的甾醇的前体。胆固醇和甘油三酯在血液中循环，作为脂蛋白复合物的一部分。通过超速离心，这些复合物分离成HDL（高密度脂蛋白）、IDL（中密度脂蛋白）、LDL（低密度脂蛋白）和VLDL（极低密度脂蛋白）部分。肝脏中的甘油三酯（TG）和胆固醇被结合到VLDL中并释放到血浆中以输送到外周组织。LDL由VLDL形成，主要通过高亲和力LDL受体分解代谢。临床和病理研究表明，血浆总胆固醇（.-C）、LDL-胆固醇（LDL-C）和载脂蛋白B（apo B）水平的升高促进人动脉粥样硬化，是发生心血管疾病的危险因素，而HDL-C水平的升高则与降压有关。降低心血管风险。
在动物模型中，LIPITOR通过抑制肝脏中的HMG-CoA还原酶和胆固醇合成来降低血浆胆固醇和脂蛋白水平，并通过增加细胞表面的肝LDL受体数量来增强LDL的摄取和分解代谢；d LDL颗粒数。LIPITOR降低纯合子家族性高胆固醇血症（FH）患者的LDL-C，该人群很少对其他降脂药物产生反应。
各种临床研究显示，升高的总C、LDL-C和载脂蛋白B（LDL-C的膜复合物）水平可促进人类动脉粥样硬化。同样，HDL-C水平降低（及其转运复合物，载脂蛋白A）与动脉粥样硬化的发展有关。流行病学调查表明，心血管疾病的发病率和死亡率与总C和LDL-C水平直接相关，与HDL-C水平相反。
LIPITOR可降低纯合和杂合FH、非家族性高胆固醇血症和混合性血脂异常患者的总C、LDL-C和载脂蛋白B。立普妥还降低VLDL-C和TG，并产生HDL-C和载脂蛋白A-1的可变增加。LIPITOR降低总C、LDL-C、VLDL-C、载脂蛋白B、TG和非HDL-C，并增加孤立性高甘油三酯血症患者的HDL-C。立普妥可降低脂蛋白血症患者的中密度脂蛋白胆固醇（IDL C）水平。
和LDL一样，富含胆固醇的甘油三酯的脂蛋白，包括VLDL、中密度脂蛋白（IDL）和残余物，也能促进动脉粥样硬化。血浆甘油三酯升高经常出现在HDL-C水平低和低密度脂蛋白颗粒小的三联体中，并与冠心病的非脂质代谢危险因素有关。因此，总的血浆TG并没有被证明是冠心病的独立危险因素。此外，升高HDL或降低TG对冠心病和心血管发病率和死亡率的独立作用尚未确定。
适应症及用法
立普妥是一种HMG-CoA还原酶抑制剂（他汀类），被认为是饮食的辅助疗法：
减少冠心病、脑卒中、血运重建程序和心绞痛的风险，但不伴有冠心病危险因素。
降低没有冠心病的2型糖尿病患者的MI和卒中风险，但有多个危险因素。
降低非致命性心肌梗塞、致命性和非致命性卒中、血管重建手术、CHF住院和冠心病患者心绞痛的风险。
降低成人原发性高脂血症（杂合性家族性和非家族性）和混合性血脂异常患者的总C、LDL-C、载脂蛋白B和TG水平升高，并增加HDL-C。
降低高甘油三酯血症和原发性β-脂蛋白血症患者的TG升高。
降低纯合子家族性高胆固醇血症（HOFH）患者总C和LDL-C水平。
在饮食疗法试验失败后，降低10至17岁的男孩和月经后女孩中总C、LDL-C和载脂蛋白B水平升高，并伴有杂合性家族性高胆固醇血症。
使用限制
立普妥在弗雷德里克松Ⅰ型和V型血脂异常中尚未被研究。
剂量与给药
剂量范围：每天10mg～80mg。
推荐起始剂量：每天10或20mg。
需要大LDL-C降低（＞45%）的患者可以开始每天40毫克。
儿科起始剂量：每天10mg，最大推荐剂量：每天20毫克。
剂型和强度
10, 20, 40片，80mg片剂。
禁忌症
活动性肝病，可能包括不明原因的肝脏转氨酶持续升高。
怀孕或可能怀孕的妇女。
哺乳期母亲。
对这种药物的任何成分过敏。
警告和注意事项
骨骼肌效应（例如，肌病和横纹肌溶解）：当高剂量与环孢素和强的CYP3A4抑制剂（例如，克拉霉素、伊曲康唑、HIV蛋白酶抑制剂）同时使用时，风险增加。易感因素包括高龄（＞65）、未控制的甲状腺功能减退和肾损害。据报道，罕见的横纹肌溶解症和急性肾功能衰竭继发于肌红蛋白尿。建议患者及时向医生报告不明原因和/或持续性肌肉疼痛、压痛或虚弱。如果肌病被诊断或怀疑，应停止使用立普妥治疗。
肝酶异常：肝转氨酶的持续升高可能发生。在开始治疗之前检查肝酶试验，然后在临床上指出。
与安慰剂组相比，LIPITOR 80mg组在没有冠心病、但在前6个月内有中风或TIA的患者中出血性中风的发生率更高。
不良反应
在安慰剂对照试验中，使用LIPITOR治疗的患者最常见的不良反应（发生率≥2%）是鼻咽炎、关节痛、腹泻、四肢疼痛和泌尿道感染，而不考虑其因果关系。
要报告预期的不良反应，请联系辉瑞（1-800-438-1985和www.pfizer.com）或FDA（1-800-FDA-1088）或www.fda.gov/med.。
药物相互作用
与肌病/横纹肌溶解症风险增加相关的药物相互作用。
相互作用剂                               处方建议
环孢菌素、HIV蛋白酶抑制剂              避免阿托伐他汀
（噻拉那韦联合利托那韦）、
丙型肝炎蛋白酶抑制剂（泰拉普雷）
HIV蛋白酶抑制剂（洛匹那韦联合利托那韦） 谨慎使用，最低剂量
克拉霉素、伊曲康唑、                  每日不超过20毫克阿托伐他汀
HIV蛋白酶抑制剂(沙奎那韦加利托那韦、
达鲁那韦加利托那韦、福沙那韦、
福沙那韦加利托那韦)                  每日不超过40毫克阿托伐他汀
HIV蛋白酶抑制剂（奈非那韦）
丙型肝炎蛋白酶抑制剂
其他降脂药物：与纤维质产品或调脂剂量（≥1g/天）烟酸一起使用会增加骨骼肌副作用的风险。当使用立普妥处方时应谨慎使用。
Digoxin：应该对病人进行适当的监测。
口服避孕药：炔诺酮和炔雌醇的价值可能会增加。
利福平应同时与立普妥联合用药。
在特定人群中的使用
肝损害：慢性酒精性肝病患者血浆浓度显著升高。
如何供应/储存和搬运
由ApHeNA制药解决方案重新包装。
有关可用配置的重新包装信息。
ApHNA药物溶液
10毫克片剂：编码“PD 155”一侧和“10”的另一个。
NDC 071-0155-23瓶90
NDC 071-0155-34瓶5000
NDC 071-0155-40 10×10单位剂量水疱
20毫克片剂：编码“PD 156”一侧和“20”的另一个。
NDC 071-0156 23瓶90
NDC 071-0156—40×10×10单位剂量水泡
NDC 071-0156—92瓶5000
40毫克片剂：编码“PD 157”一侧和“40”的另一个。
NDC 071-0157 23瓶90
NDC 071-0157—72瓶500
NDC 071-0157—88瓶2500
NDC 071-0157—40×10×10单位剂量水疱
80毫克片剂：编码“PD 158”一侧和“80”的另一个。
NDC 071-0158 23瓶90
NDC 071-0158－72瓶500
NDC 071-0158 88瓶2500
NDC 071-015892×8×8单位剂量水泡
保管部
在室温20～25℃（68～77°F）下储存（参见USP）。
完整资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7fe85155-bc00-406b-b097-e8aece187a8a
Lipitor(Atorvastatin calcium)
IMPORTANT SAFETY INFORMATION AND INDICATIONS
LIPITOR® (atorvastatin calcium) tablets are not for everyone, including anyone who has previously had an allergic reaction to LIPITOR. It is not for those with liver problems. And it is not for women who are nursing, pregnant, or may become pregnant. If you get pregnant, stop taking LIPITOR and call your doctor right away.
If you take LIPITOR, tell your doctor if you feel any new muscle pain or weakness. This could be a sign of rare but serious muscle problems that can lead to kidney problems, including kidney failure.
Tell your doctor about all your medical conditions and all medications you take. This may help avoid serious drug interactions. Your doctor should do blood tests to check your liver function before starting LIPITOR and during your treatment if you have symptoms of liver problems. Call your doctor right away if you have the following symptoms of liver problems - feel tired or weak or have a loss of appetite, upper belly pain, dark amber colored urine or yellowing of your skin or the whites of your eyes.
Tell your doctor if you have diabetes. Elevated blood sugar levels have been reported with statins, including LIPITOR.
Common side effects are diarrhea, upset stomach, muscle and joint pain, and changes in some blood tests.
Talk to your healthcare provider if you have side effects that bother you or that will not go away.
INDICATIONS
LIPITOR is a prescription medicine that lowers cholesterol in the blood. It lowers the LDL-C ("bad” cholesterol) and triglycerides in your blood. It can raise your HDL-C ("good" cholesterol) as well. LIPITOR is for adults and children over 10 whose cholesterol does not come down enough with exercise and a low-fat diet alone.
LIPITOR can lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as age, smoking, high blood pressure, low HDL-C, or heart disease in the family. LIPITOR can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as eye problems, kidney problems, smoking, or high blood pressure.
Limitations of Use: LIPITOR has not been studied in people who have an increase of chylomicrons (Fredrickson Types I and V).
Please see Full Prescribing Information and Patient Information.
LIPITOR SAVINGS CARD TERMS AND CONDITIONS
By participating in the LIPITOR Savings Offer Program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
This Savings Offer is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, Tricare, or other federal or state healthcare programs (including any state prescription drug assistance programs) and the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”)
You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
Eligible patients will pay a minimum of $4 per monthly prescription fill. By using the Savings Offer, eligible patients will receive a savings of up to $150 per fill off their co-pay or out-of-pocket costs. The Savings Offer is good for a maximum savings of $1,800 per year ($150 per month x 12 months). The Savings Offer limits your prescription cost to $4, subject to a maximum $150 monthly benefit. Thus, if your co-pay or out-of-pocket cost is more than $150, you will save $150 off of your co-pay or total out-of-pocket costs. [Example: If your co-pay or out-of-pocket costs are $175, you will pay $25 ($175 – $150 = $25).] If your co-pay or out-of-pocket costs are no more than $150, you pay $4. For a mail-order 3-month prescription, your total maximum savings will be $450 ($150 x 3)
This Savings Offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs
The Savings Offer is not valid for Massachusetts residents whose prescriptions are covered, in whole or in part, by third-party insurance
This Savings Offer is not valid where prohibited by law
The Savings Offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
The Savings Offer may not be redeemed more than once per month per patient
The Savings Offer will be accepted only at participating pharmacies
The Savings Offer is not health insurance
This Savings Offer is good only in the U.S. and Puerto Rico
The Savings Offer is limited to 1 per person during this offering period and is not transferable
Pfizer reserves the right to rescind, revoke, or amend the program without notice
No membership fees. The Savings Offer and Program expire on 12/31/2020
For reimbursement when using a nonparticipating pharmacy/mail order: Pay for your LIPITOR prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: LIPITOR Savings Offer, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to include a copy of the front of your LIPITOR Savings Card, your name, and mailing address.
Patients should always ask their doctors for medical advice about adverse events.
You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.
The product information provided in this site is intended for residents of the United States. The products discussed herein may have different product labeling in different countries.